Complete Neoadjuvant Treatment for REctal Cancer (CONTRE)

NCT01363843 | Completed Phase 2 Results DMC

• 1 other identifier: BrUOG 224
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to find out how well patients with cancer of the rectum do if they get all of their other treatment - chemotherapy by itself followed by chemotherapy and radiation together - before surgery. Patients have recently been diagnosed with rectal cancer, and the doctors have recommended neo-adjuvant chemo treatment to try to shrink the cancer before removing it.

Conditions

Colon Cancer; Rectal Cancer

Keywords

neoadjuvant; chemo/radiation; rectal cancer; rectum cancer; colon cancer; colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Complete Resection

  The primary objective of this study is to determine the incidence of pCRs and complete (R0) resections at surgery after induction chemotherapy with 8 cycles of modified FOLFOX6 followed by standard chemoradiation with IMRT with concurrent infusional 5-FU or capecitabine

  approx 6 months

Secondary Outcomes (1)

• Evaluate the Toxicity of Study Therapy

  approx 1 year

Study Arms (1)

treatment

EXPERIMENTAL

Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles Concurrent Chemoradiation 50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost) Surgery

Drug: FOLFOX6; Radiation: RT with concurrent chemotherapy; Procedure: Surgery

Interventions

FOLFOX6 DRUG

FOLFOX6

Also known as: Oxaliplatin 85 mg/m2, Leucovorin 400 mg/m2 IV, 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours

treatment

RT with concurrent chemotherapy RADIATION

IMRT 50.4Gy with chemotherapy

treatment

Surgery PROCEDURE

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically proven adenocarcinoma of the rectum with no evidence of distant metastases.
• The tumor must be clinically Stage II (T3-4 N0 with N0 being defined as all imaged lymph nodes are \< 1.0cm) or III (T1-4 N1-2 with the definition of a clinically positive node being any node \> 1.0cm). Stage of the tumor may be determined by CT scan, endorectal ultrasound or MRI.
• Patients must have no evidence of distant metastases including liver metastases, peritoneal seeding, or inguinal lymphadenopathy.
• Patients must not have received prior chemotherapy or pelvic radiation for rectal cancer, or prior pelvic radiation for any other malignancy that would prevent the patient from receiving the required radiation treatments for this study.
• Patients must have a life expectancy of 5 years, excluding their diagnosis of cancer (as determined by the investigator).
• Patients must not have an active concurrent invasive malignancy. Patients with prior malignancies, including invasive colon cancer, are eligible if they are deemed by their physician to be at low risk for recurrence. Patients with squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma of the cervix, or carcinoma in situ of the colon or rectum that have been effectively treated are eligible, even if these conditions were diagnosed within 5 years prior to randomization.
• Patients must be \> 18 years of age, ECOG performance status 0-1.
• ANC \> 1,500/µl, platelets \> 100,000/µl, total bilirubin \< 2.0 mg/dl or direct bilirubin \< 1.0 mg/dl, alkaline phosphatase \< 3xULN, ALT \< 3xULN, creatinine \< 1.5xULN.
• The patient must have been evaluated by a surgeon, radiation oncologist and medical oncologist and all must concur that the patient is appropriate for this study.
• Signed informed consent; able to comply with study and/or follow- up procedures
• Peripheral neuropathy \< grade 1

You may not qualify if:

• Evidence of metastatic disease.
• Rectal cancers other than adenocarcinoma, i.e., sarcoma, lymphoma, carcinoid, squamous cell carcinoma, cloacogenic carcinoma, etc.
• Pregnancy or lactation at the time of proposed randomization. Eligible patients of reproductive potential (both sexes) must agree to use adequate contraception.
• Any therapy for this cancer prior to randomization.
• Synchronous invasive colon cancer.
• Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the patient from receiving any chemotherapy treatment option or would prevent required follow-up.
• Patients with active inflammatory bowel disease, abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to Day 0 or other serious medical illness which might limit the ability of the patient to receive protocol therapy.
• Prior pelvic irradiation for any indication.
• Known hypersensitivity to 5-fluorouracil or oxaliplatin
• Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.

Sponsors & Collaborators

• William Sikov MD: lead
• Memorial Hospital of Rhode Island: collaborator
• Rhode Island Hospital: collaborator
• The Miriam Hospital: collaborator

Study Sites (3)

Memorial Hospital

Pawtucket, Rhode Island, 02860, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Colorectal Neoplasms

Interventions

Folfox protocol; Oxaliplatin; Leucovorin; Fluorouracil; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: William Sikov, MD and Kimberly Perez, MD
• Organization: BrUOG

kayla_rosati@brown.edu

4018633000

Study Officials

• William Sikov, MD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: May 26, 2011
• First Posted: June 2, 2011
• Study Start: May 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: June 11, 2020
• Results First Posted: July 16, 2014

Record last verified: 2020-05

Locations

US (3)